Early ART for HIV

(EARLIER Trial)

Recruiting at36 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study was done to: * Start antiretroviral therapy (ART) early in those recently or acutely infected with HIV-1 * See how starting ART as soon as the infection is found affects the amount of HIV-1 in blood and how well the body fights the HIV-1 infection * Look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells (infection-fighting cells in blood) after 48 weeks of ART * See how early treatment for HIV affects the numbers of HIV-1 infection fighting cells (CD4+ and CD8+ T-cells) in blood

Research Team

Eligibility Criteria

This trial is for individuals recently diagnosed with acute HIV-1 infection who can start treatment immediately and are willing to follow the study plan for up to 72 weeks. Women of childbearing potential must use contraception, and participants should not have any health conditions that could affect their participation or be on immune-modifying drugs.

Inclusion Criteria

I have discussed the safety of my ARV regimen during pregnancy with my doctor.

I am ready and willing to start antiretroviral therapy at enrollment.

I am a woman capable of becoming pregnant.

Exclusion Criteria

Any acute, chronic, or recent and clinically significant medical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements or jeopardize the safety or rights of the participant

I haven't used HIV prevention drugs in the 60 days before my acute HIV infection diagnosis.

I regularly take medication that affects my immune system, like steroids.

Treatment Details

Interventions

• bictegravir/emtricitabine/tenofovir alafenamide (Antiretroviral Therapy)
• elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Antiretroviral Therapy)

Trial Overview The trial tests early antiretroviral therapy (ART) using FDA-approved medications like elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide among others. It aims to see how early ART affects HIV-1 levels in blood, the body's response, and the amount of virus in CD4+ T-cells after 48 weeks.

Participant Groups

Group I: Arm 3: Fiebig V Experimental Treatment 1 Intervention

Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).

Group II: Arm 2: Fiebig III/IV Experimental Treatment 1 Intervention

Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).

Group III: Arm 1: Fiebig I/II Experimental Treatment 1 Intervention

Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).

bictegravir/emtricitabine/tenofovir alafenamide is already approved in Canada, Japan, Switzerland for the following indications:

Approved in Canada as Biktarvy for:

• HIV-1 infection

Approved in Japan as Biktarvy for:

• HIV-1 infection

Approved in Switzerland as Biktarvy for:

• HIV-1 infection

Who Is Running the Clinical Trial?

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Lead Sponsor

Trials

103

Recruited

74,200+

Dr. Joseph J. Eron Jr.

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Chief Executive Officer

MD from Harvard Medical School

Dr. James McNamara

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Chief Medical Officer since 2023

MD from Harvard Medical School

AIDS Clinical Trials Group

Lead Sponsor

Trials

101

Recruited

73,600+

Dr. Diane V. Havlir

AIDS Clinical Trials Group

Chief Executive Officer since 2023

MD from Stanford University

Dr. Wafaa M. El-Sadr

AIDS Clinical Trials Group

Chief Medical Officer since 2023

MD from Columbia University

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Dr. Jeanne Marrazzo

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Executive Officer since 2023

MD, MPH

Dr. H. Clifford Lane

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Medical Officer

MD